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510(k) K222212

ivWatch Model 400 by Ivwatch, LLC — Product Code PMS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2022
Date Received
July 25, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peripheral Intravenous (Piv) Infiltration Monitor
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.

Other clearances by Ivwatch, LLC

  • K233881 — ivWatch® Model 400 (March 15, 2024)
  • K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Pati (July 2, 2020)
  • K162478 — ivWatch (December 22, 2016)
  • K153605 — ivWatch Model 400 (February 11, 2016)
  • K142374 — ivWatch Model 400 (February 13, 2015)

Other clearances for product code PMS

  • K233881 — ivWatch® Model 400 (March 15, 2024)
  • K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Pati (July 2, 2020)
  • K162478 — ivWatch (December 22, 2016)
  • K153605 — ivWatch Model 400 (February 11, 2016)